Durvalumab

Generic Name
Durvalumab
Brand Names
Imfinzi
Drug Type
Biotech
Chemical Formula
-
CAS Number
1428935-60-7
Unique Ingredient Identifier
28X28X9OKV
Background

Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment. Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture, durvalumab is a programmed death-ligand 1 (PD-L1) blocking antibody that works to promote normal immune responses that attack tumour cells.

Durvalumab is marketed under the brand name Imfinzi, which is available for intravenous injections. It was granted accelerated approval by the FDA in May 2017 for the treatment of selected patients with locally advanced or metastatic urothelial carcinoma. In September 2018, durvalumab was approved by the EMA for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC), only if PD-L1 is expressed in ≥ 1% of tumour cells and there was no observable disease progression following platinum-based chemoradiation therapy. On March 27, 2020, durvalumab was approved by the FDA for use in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

Indication

Durvalumab is indicated for the treatment of adults with the following conditions:

Associated Conditions
Extensive-stage Small Cell Lung Cancer (SCLC), Locally Advanced Biliary Tract Cancer, Metastatic Biliary Tract Cancer, Metastatic Non-Small Cell Lung Cancer, Unresectable Hepatocellular Carcinoma (HCC), Unresectable Stage III Non-small Cell Lung Cancer, Unresectable, locally advanced PD-L1 positive Lung Cancer Non-Small Cell Cancer (NSCLC)
Associated Therapies
First Line Chemotherapy

Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer

First Posted Date
2020-11-03
Last Posted Date
2024-12-16
Lead Sponsor
AstraZeneca
Target Recruit Count
371
Registration Number
NCT04612751
Locations
🇹🇷

Research Site, Malatya, Turkey

Efficacy and Safety of Standard of Care Plus Durvalumab in Patients With Limited Disease Small Cell Lung Cancer (DOLPHIN)

First Posted Date
2020-10-26
Last Posted Date
2023-06-05
Lead Sponsor
Michael Hopp
Target Recruit Count
105
Registration Number
NCT04602533
Locations
🇩🇪

Klinik Löwenstein gGmbH, Löwenstein, Baden-Würtemberg, Germany

🇩🇪

Sana-Klinikum Offenbach, Offenbach, Hessen, Germany

🇩🇪

Lungenklinik Hemer, Hemer, NRW, Germany

and more 9 locations

Durvalumab and Low-dose PCI vs Durvalumab and Observation in Radically Treated Patients With Stage III NSCLC (NVALT28)

First Posted Date
2020-10-22
Last Posted Date
2023-06-05
Lead Sponsor
Association NVALT Studies
Target Recruit Count
170
Registration Number
NCT04597671
Locations
🇳🇱

ZGT, Almelo, Netherlands

🇳🇱

Gelderse Vallei, Ede, Netherlands

🇳🇱

Maastro, Maastricht, Netherlands

and more 11 locations

Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer

First Posted Date
2020-10-19
Last Posted Date
2024-12-13
Lead Sponsor
AstraZeneca
Target Recruit Count
958
Registration Number
NCT04592913
Locations
🇬🇧

Research Site, Surrey, United Kingdom

Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)

First Posted Date
2020-10-14
Last Posted Date
2024-06-21
Lead Sponsor
Stanford University
Target Recruit Count
80
Registration Number
NCT04585477
Locations
🇺🇸

Stanford University, Stanford, California, United States

Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC

First Posted Date
2020-10-14
Last Posted Date
2024-04-17
Lead Sponsor
Maximilian Diehn
Target Recruit Count
48
Registration Number
NCT04585490
Locations
🇺🇸

Stanford University, Stanford, California, United States

Neoadjuvant Durvalumab Alone Versus Durvalumab With Olaparib in Patients Ineligible for Cisplatin With Muscle-Invasive Urothelial Carcinoma of the Bladder Followed by Radical Cystectomy

First Posted Date
2020-10-08
Last Posted Date
2021-06-16
Lead Sponsor
Latin American Cooperative Oncology Group
Target Recruit Count
140
Registration Number
NCT04579133
Locations
🇧🇷

Centro de Pesquisa em Oncologia, Porto Alegre, Brazil

Study of Anti-PD-L1 in Combination With Chemo(Radio)Therapy for Resectable Esophageal Squamous Cell Carcinoma

First Posted Date
2020-09-29
Last Posted Date
2024-01-22
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
60
Registration Number
NCT04568200
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, Beijing, China

A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer

First Posted Date
2020-09-21
Last Posted Date
2024-11-25
Lead Sponsor
AstraZeneca
Target Recruit Count
138
Registration Number
NCT04556773
Locations
🇨🇳

Research Site, Taoyuan, Taiwan

A Platform Study of Novel Agents in Combination With Radiotherapy in NSCLC

First Posted Date
2020-09-16
Last Posted Date
2024-02-26
Lead Sponsor
University of Leeds
Target Recruit Count
200
Registration Number
NCT04550104
Locations
🇬🇧

Addenbrooke's Hospital, Cambridge, United Kingdom

🇬🇧

Belfast City Hospital, Belfast, United Kingdom

🇬🇧

Freeman Hospital, Newcastle upon Tyne Hospitals NHS Trust, Newcastle Upon Tyne, United Kingdom

and more 8 locations
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